Accelerated infliximab infusions for inflammatory bowel disease improve effectiveness
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摘要
AIM:To study the safety and effectiveness associated with accelerated infliximab infusion protocols in patients with inflammatory bowel disease(IBD).METHODS:Original protocols and infusion rates were developed for the administration of infliximab over 90-min and 60-min.Then the IBD patients on stable maintenance infliximab therapy were offered accelerated infusions.To be eligible for the study,patients needed a minimum of four prior infusions.An initial infusion of 90-min was given to each patient;those tolerating the accelerated infusion were transitioned to a 60-min infusion protocol at their next and all subsequent visits.Any patient having significant infusion reactions would be reverted to the standard 120-min protocol.A change in a patient's dose mandated a single 120-min infusion before accelerated infusions could be administered again.RESULTS:The University of Virginia Medical Center's Institutional Review Board approved this study.Fifty IBD patients treated with infliximab 5mg/kg,7.5mg/kg and 10mg/kg were offered accelerated infusions.Forty-six patients consented to participate in the study.Nineteen(41.3%) were female,five(10.9%) were African American and nine(19.6%) had ulcerative colitis.The mean age was 42.6 years old.Patients under age 18 were excluded.Ten patients used immunosuppressive drugs concurrently out of which six were taking azathioprine,three were taking 6-mercaptopurine and one was taking methotrexate.One of the 46 study patients used corticosteroid therapy for his IBD.Seventeen of the patients used prophylactic medications prior to receiving infusions;six patients received corticosteroids as pre-medication.Four patients had a history of distant transfusion reactions to infliximab.These reactions included shortness of breath,chest tightness,flushing,pruritus and urticaria.These patients all took prophylactic medications before receiving infusions.46 patients(27 males and 19 females) received a total of fifty 90-min infusions and ninety-three 60-min infusions.No infusion reactions were reported.There were no adverse events,including drug-related infections.None of the patients developed cancer of any type during the study timeframe.Total cost savings for administration of the both 90-min and 60-min accelerated infusions compared to standard 120-min infusions was estimated to be $53 632($116 965 vs $63 333,P=0.001).One hundred and eighteen hours were saved in the administration of the accelerated infusions(17 160 min vs 10 080 min,P=0.001).In the study population,overweight females [body mass index(BMI)>25.00kg/m2] were found to have statistically higher BMIs than overweight males(mean BMI 35.07±2.66kg/m2 vs 30.08±0.99kg/m2,P=0.05),finding which is of significance since obesity was described as being one of the risk factors for Crohn's disease.CONCLUSION:We are the first US group to report substantial cost savings,increased safety and patient satisfaction associated with accelerated infliximab infusion.
AIM:To study the safety and effectiveness associated with accelerated infliximab infusion protocols in patients with inflammatory bowel disease(IBD).METHODS:Original protocols and infusion rates were developed for the administration of infliximab over 90-min and 60-min.Then the IBD patients on stable maintenance infliximab therapy were offered accelerated infusions.To be eligible for the study,patients needed a minimum of four prior infusions.An initial infusion of 90-min was given to each patient;those tolerating the accelerated infusion were transitioned to a 60-min infusion protocol at their next and all subsequent visits.Any patient having significant infusion reactions would be reverted to the standard 120-min protocol.A change in a patient's dose mandated a single 120-min infusion before accelerated infusions could be administered again.RESULTS:The University of Virginia Medical Center's Institutional Review Board approved this study.Fifty IBD patients treated with infliximab 5mg/kg,7.5mg/kg and 10mg/kg were offered accelerated infusions.Forty-six patients consented to participate in the study.Nineteen(41.3%) were female,five(10.9%) were African American and nine(19.6%) had ulcerative colitis.The mean age was 42.6 years old.Patients under age 18 were excluded.Ten patients used immunosuppressive drugs concurrently out of which six were taking azathioprine,three were taking 6-mercaptopurine and one was taking methotrexate.One of the 46 study patients used corticosteroid therapy for his IBD.Seventeen of the patients used prophylactic medications prior to receiving infusions;six patients received corticosteroids as pre-medication.Four patients had a history of distant transfusion reactions to infliximab.These reactions included shortness of breath,chest tightness,flushing,pruritus and urticaria.These patients all took prophylactic medications before receiving infusions.46 patients(27 males and 19 females) received a total of fifty 90-min infusions and ninety-three 60-min infusions.No infusion reactions were reported.There were no adverse events,including drug-related infections.None of the patients developed cancer of any type during the study timeframe.Total cost savings for administration of the both 90-min and 60-min accelerated infusions compared to standard 120-min infusions was estimated to be $53 632($116 965 vs $63 333,P=0.001).One hundred and eighteen hours were saved in the administration of the accelerated infusions(17 160 min vs 10 080 min,P=0.001).In the study population,overweight females [body mass index(BMI)>25.00kg/m2] were found to have statistically higher BMIs than overweight males(mean BMI 35.07±2.66kg/m2 vs 30.08±0.99kg/m2,P=0.05),finding which is of significance since obesity was described as being one of the risk factors for Crohn's disease.CONCLUSION:We are the first US group to report substantial cost savings,increased safety and patient satisfaction associated with accelerated infliximab infusion.
AIM:To study the safety and effectiveness associated with accelerated infliximab infusion protocols in patients with inflammatory bowel disease(IBD).METHODS:Original protocols and infusion rates were developed for the administration of infliximab over 90-min and 60-min.Then the IBD patients on stable maintenance infliximab therapy were offered accelerated infusions.To be eligible for the study,patients needed a minimum of four prior infusions.An initial infusion of 90-min was given to each patient;those tolerating the accelerated infusion were transitioned to a 60-min infusion protocol at their next and all subsequent visits.Any patient having significant infusion reactions would be reverted to the standard 120-min protocol.A change in a patient's dose mandated a single 120-min infusion before accelerated infusions could be administered again.RESULTS:The University of Virginia Medical Center's Institutional Review Board approved this study.Fifty IBD patients treated with infliximab 5mg/kg,7.5mg/kg and 10mg/kg were offered accelerated infusions.Forty-six patients consented to participate in the study.Nineteen(41.3%) were female,five(10.9%) were African American and nine(19.6%) had ulcerative colitis.The mean age was 42.6 years old.Patients under age 18 were excluded.Ten patients used immunosuppressive drugs concurrently out of which six were taking azathioprine,three were taking 6-mercaptopurine and one was taking methotrexate.One of the 46 study patients used corticosteroid therapy for his IBD.Seventeen of the patients used prophylactic medications prior to receiving infusions;six patients received corticosteroids as pre-medication.Four patients had a history of distant transfusion reactions to infliximab.These reactions included shortness of breath,chest tightness,flushing,pruritus and urticaria.These patients all took prophylactic medications before receiving infusions.46 patients(27 males and 19 females) received a total of fifty 90-min infusions and ninety-three 60-min infusions.No infusion reactions were reported.There were no adverse events,including drug-related infections.None of the patients developed cancer of any type during the study timeframe.Total cost savings for administration of the both 90-min and 60-min accelerated infusions compared to standard 120-min infusions was estimated to be $53 632($116 965 vs $63 333,P=0.001).One hundred and eighteen hours were saved in the administration of the accelerated infusions(17 160 min vs 10 080 min,P=0.001).In the study population,overweight females [body mass index(BMI)>25.00kg/m2] were found to have statistically higher BMIs than overweight males(mean BMI 35.07±2.66kg/m2 vs 30.08±0.99kg/m2,P=0.05),finding which is of significance since obesity was described as being one of the risk factors for Crohn's disease.CONCLUSION:We are the first US group to report substantial cost savings,increased safety and patient satisfaction associated with accelerated infliximab infusion.
引文
1 Infliximab-full prescribing information. PA: Centocor Biotech,Inc.,2012 [cited 2012 June 4]
2 Lee TW,Singh R,Fedorak RN. A one-hour infusion of infliximab during maintenance therapy is safe and well tolerated: a prospective cohort study. Aliment Pharmacol Ther 2011; 34: 181-187
3 Bhat S,Sharma D,Doherty P,Tham TC,Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis 2010; 16: 1922-1925
4 Breynaert C,Ferrante M,Fidder H,Van Steen K,Noman M, Ballet V,Vermeire S,Rutgeerts P,Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol 2011; 106: 778-785
5 Van Assche G,Vermeire S,Noman M,Amant C,Weyts E, Vleminckx A,Vermeyen MJ,Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis 2010; 4: 329-333
6 Rutgeerts P,Van Assche G,Vermeire S. Review article: Infliximab therapy for inflammatory bowel disease--seven years on. Aliment Pharmacol Ther 2006; 23: 451-463
7 Compilation of Patient Protection and Affordable Care Act, 2010. Available from: URL: http://www.communityhlth. org/communityhlth/files/files_resource/Community%20Benefit/PPACA-Sec9007-tax-exempt-hospitals.pdf
8 D’Haens G,Baert F,van Assche G,Caenepeel P,Vergauwe P,Tuynman H,De Vos M,van Deventer S,Stitt L,Donner A,Vermeire S,Van de Mierop FJ,Coche JC,van der Woude J,Ochsenkühn T,van Bodegraven AA,Van Hootegem PP, Lambrecht GL,Mana F,Rutgeerts P,Feagan BG,Hommes D. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet 2008; 371: 660-667
9 Sohrabpour AA,Malekzadeh R,Keshavarzian A. Current therapeutic approaches in inflammatory bowel disease. Curr Pharm Des 2010; 16: 3668-3683
10 Rutgeerts P,Sandborn WJ,Feagan BG,Reinisch W,Olson A, Johanns J,Travers S,Rachmilewitz D,Hanauer SB,Lichtenstein GR,de Villiers WJ,Present D,Sands BE,Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462-2476
11 Behm BW,Bickston SJ. Efficacy of infliximab for luminal and fistulizing Crohn’s disease and in ulcerative colitis. Curr Treat Options Gastroenterol 2007; 10: 171-177
12 Nguyen GC,Tuskey A,Dassopoulos T,Harris ML,Brant SR. Rising hospitalization rates for inflammatory bowel disease in the United States between 1998 and 2004. Inflamm Bowel Dis 2007; 13: 1529-1535
13 Singh JA,Wells GA,Christensen R,Tanjong Ghogomu E, Maxwell L,Macdonald JK,Filippini G,Skoetz N,Francis D, Lopes LC,Guyatt GH,Schmitt J,La Mantia L,Weberschock T,Roos JF,Siebert H,Hershan S,Lunn MP,Tugwell P,Buchbinder R. Adverse effects of biologics: a network metaanalysis and Cochrane overview. Cochrane Database Syst Rev 2011; (2): CD008794
14 Curtis JR,Patkar N,Xie A,Martin C,Allison JJ,Saag M,Shatin D,Saag KG. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007; 56: 1125-1133
15 Rosenblum H,Amital H. Anti-TNF therapy: safety aspectsof taking the risk. Autoimmun Rev 2011; 10: 563-568
16 Cheifetz A,Smedley M,Martin S,Reiter M,Leone G,Mayer L,Plevy S. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol 2003; 98: 1315-1324
17 Cheifetz A,Mayer L. Monoclonal antibodies,immunogenicity,and associated infusion reactions. Mt Sinai J Med 2005;72: 250-256
18 Ducourau E,Mulleman D,Paintaud G,Miow Lin DC,Lauféron F,Ternant D,Watier H,Goupille P. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. Arthritis Res Ther 2011; 13: R105
19 Farrell RJ,Alsahli M,Jeen YT,Falchuk KR,Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn’s disease: a randomized controlled trial. Gastroenterology 2003; 124: 917-924
20 Maini RN,Breedveld FC,Kalden JR,Smolen JS,Davis D, Macfarlane JD,Antoni C,Leeb B,Elliott MJ,Woody JN, Schaible TF,Feldmann M. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41: 1552-1563
21 Mori S. A relationship between pharmacokinetics (PK) and the efficacy of infliximab for patients with rheumatoid arthritis: characterization of infliximab-resistant cases and PKbased modified therapy. Mod Rheumatol 2007; 17: 83-91
22 Blain A,Cattan S,Beaugerie L,Carbonnel F,Gendre JP, Cosnes J. Crohn’s disease clinical course and severity in obese patients. Clin Nutr 2002; 21: 51-57
23 Mendall MA,Gunasekera AV,John BJ,Kumar D. Is obesity a risk factor for Crohn’s disease? Dig Dis Sci 2011; 56: 837-844
24 Gremese E,Carletto A,Padovan M,Atzeni F,Raffeiner B, Giardina AR,Favalli EG,Erre G,Gorla R,Galeazzi M,Foti R,Cantini F,Salvarani C,Olivieri I,Lapadula G,Ferraccioli G. Obesity and reduction of the response rate to anti-tumor necrosis factor α in rheumatoid arthritis: An approach to a personalized medicine. Arthritis Care Res (Hoboken) 2013; 65: 94-100
25 Ottaviani S,Allanore Y,Tubach F,Forien M,Gardette A, Pasquet B,Palazzo E,Meunier M,Hayem G,Job-Deslandre C,Kahan A,Meyer O,Dieudé P. Body mass index influences the response to infliximab in ankylosing spondylitis. Arthritis Res Ther 2012; 14: R115
26 Puig L. Obesity and psoriasis: body weight and body mass index influence the response to biological treatment. J Eur Acad Dermatol Venereol 2011; 25: 1007-1011
2 Lee TW,Singh R,Fedorak RN. A one-hour infusion of infliximab during maintenance therapy is safe and well tolerated: a prospective cohort study. Aliment Pharmacol Ther 2011; 34: 181-187
3 Bhat S,Sharma D,Doherty P,Tham TC,Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis 2010; 16: 1922-1925
4 Breynaert C,Ferrante M,Fidder H,Van Steen K,Noman M, Ballet V,Vermeire S,Rutgeerts P,Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol 2011; 106: 778-785
5 Van Assche G,Vermeire S,Noman M,Amant C,Weyts E, Vleminckx A,Vermeyen MJ,Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis 2010; 4: 329-333
6 Rutgeerts P,Van Assche G,Vermeire S. Review article: Infliximab therapy for inflammatory bowel disease--seven years on. Aliment Pharmacol Ther 2006; 23: 451-463
7 Compilation of Patient Protection and Affordable Care Act, 2010. Available from: URL: http://www.communityhlth. org/communityhlth/files/files_resource/Community%20Benefit/PPACA-Sec9007-tax-exempt-hospitals.pdf
8 D’Haens G,Baert F,van Assche G,Caenepeel P,Vergauwe P,Tuynman H,De Vos M,van Deventer S,Stitt L,Donner A,Vermeire S,Van de Mierop FJ,Coche JC,van der Woude J,Ochsenkühn T,van Bodegraven AA,Van Hootegem PP, Lambrecht GL,Mana F,Rutgeerts P,Feagan BG,Hommes D. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet 2008; 371: 660-667
9 Sohrabpour AA,Malekzadeh R,Keshavarzian A. Current therapeutic approaches in inflammatory bowel disease. Curr Pharm Des 2010; 16: 3668-3683
10 Rutgeerts P,Sandborn WJ,Feagan BG,Reinisch W,Olson A, Johanns J,Travers S,Rachmilewitz D,Hanauer SB,Lichtenstein GR,de Villiers WJ,Present D,Sands BE,Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462-2476
11 Behm BW,Bickston SJ. Efficacy of infliximab for luminal and fistulizing Crohn’s disease and in ulcerative colitis. Curr Treat Options Gastroenterol 2007; 10: 171-177
12 Nguyen GC,Tuskey A,Dassopoulos T,Harris ML,Brant SR. Rising hospitalization rates for inflammatory bowel disease in the United States between 1998 and 2004. Inflamm Bowel Dis 2007; 13: 1529-1535
13 Singh JA,Wells GA,Christensen R,Tanjong Ghogomu E, Maxwell L,Macdonald JK,Filippini G,Skoetz N,Francis D, Lopes LC,Guyatt GH,Schmitt J,La Mantia L,Weberschock T,Roos JF,Siebert H,Hershan S,Lunn MP,Tugwell P,Buchbinder R. Adverse effects of biologics: a network metaanalysis and Cochrane overview. Cochrane Database Syst Rev 2011; (2): CD008794
14 Curtis JR,Patkar N,Xie A,Martin C,Allison JJ,Saag M,Shatin D,Saag KG. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007; 56: 1125-1133
15 Rosenblum H,Amital H. Anti-TNF therapy: safety aspectsof taking the risk. Autoimmun Rev 2011; 10: 563-568
16 Cheifetz A,Smedley M,Martin S,Reiter M,Leone G,Mayer L,Plevy S. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol 2003; 98: 1315-1324
17 Cheifetz A,Mayer L. Monoclonal antibodies,immunogenicity,and associated infusion reactions. Mt Sinai J Med 2005;72: 250-256
18 Ducourau E,Mulleman D,Paintaud G,Miow Lin DC,Lauféron F,Ternant D,Watier H,Goupille P. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. Arthritis Res Ther 2011; 13: R105
19 Farrell RJ,Alsahli M,Jeen YT,Falchuk KR,Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn’s disease: a randomized controlled trial. Gastroenterology 2003; 124: 917-924
20 Maini RN,Breedveld FC,Kalden JR,Smolen JS,Davis D, Macfarlane JD,Antoni C,Leeb B,Elliott MJ,Woody JN, Schaible TF,Feldmann M. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41: 1552-1563
21 Mori S. A relationship between pharmacokinetics (PK) and the efficacy of infliximab for patients with rheumatoid arthritis: characterization of infliximab-resistant cases and PKbased modified therapy. Mod Rheumatol 2007; 17: 83-91
22 Blain A,Cattan S,Beaugerie L,Carbonnel F,Gendre JP, Cosnes J. Crohn’s disease clinical course and severity in obese patients. Clin Nutr 2002; 21: 51-57
23 Mendall MA,Gunasekera AV,John BJ,Kumar D. Is obesity a risk factor for Crohn’s disease? Dig Dis Sci 2011; 56: 837-844
24 Gremese E,Carletto A,Padovan M,Atzeni F,Raffeiner B, Giardina AR,Favalli EG,Erre G,Gorla R,Galeazzi M,Foti R,Cantini F,Salvarani C,Olivieri I,Lapadula G,Ferraccioli G. Obesity and reduction of the response rate to anti-tumor necrosis factor α in rheumatoid arthritis: An approach to a personalized medicine. Arthritis Care Res (Hoboken) 2013; 65: 94-100
25 Ottaviani S,Allanore Y,Tubach F,Forien M,Gardette A, Pasquet B,Palazzo E,Meunier M,Hayem G,Job-Deslandre C,Kahan A,Meyer O,Dieudé P. Body mass index influences the response to infliximab in ankylosing spondylitis. Arthritis Res Ther 2012; 14: R115
26 Puig L. Obesity and psoriasis: body weight and body mass index influence the response to biological treatment. J Eur Acad Dermatol Venereol 2011; 25: 1007-1011
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